Cleared Traditional

HBS POWDER

K820927 · Dutchland Laboratories, Inc. · Microbiology
Apr 1982
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K820927 is an FDA 510(k) clearance for the HBS POWDER, a Formulations, Balanced Salt Solutions (Class I — General Controls, product code KIP), submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982, 20 days after receiving the submission on April 1, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.2875.

Submission Details

510(k) Number K820927 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1982
Decision Date April 21, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KIP — Formulations, Balanced Salt Solutions
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2875

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